FDAClass IIApril 15, 2015

Glipizide and Metformin Hydrochloride Tablets recall: Impurity Out of Spec

GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown…

Why was Glipizide and Metformin Hydrochloride Tablets recalled?

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #:18020994, Expiry: October 2015; Lot #: 18021311, Expiry: November 2015.

Product
GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown…
Recalling firm
Heritage Pharmaceuticals, Inc.
Quantity
6,816 Bottles
Distribution
U.S. Nationwide including Puerto Rico.
Recall date
April 15, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls